FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUTEINIZING HORMONE-EIA-XT
K Number: K896866
·
Decision Feb 13, 1990
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
15
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LUTEINIZING HORMONE-EIA-XT
- K Number
- K896866
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- In Vitro Diagnostics, Inc.
- Date Received
- December 6, 1989
- Decision Date
- February 13, 1990
- Product Code
- CEP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEP), ordered by most recent decision date.
MAYBE?MOM MINI OVULATION MICROSCOPE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INSTANT-VIEW LH OVULATION PREDICTING TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AT HOME OVULATION TEST, MODEL 9032
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARPLANE EASY OVULATION TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TCI-31 LIFELONG OVULATION TESTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUIK-CHECK OVULATION PREDICTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by In Vitro Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896867 | THYROID STIMULATING HORMONE-EIA-XT | Feb 23, 1990 | Substantially Equivalent |
| K896863 | DIGOXIN-EIA-XT | Feb 13, 1990 | Substantially Equivalent |
| K896865 | VITRO T4-EIA-XT | Jan 30, 1990 | Substantially Equivalent |
| K896925 | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT | Jan 18, 1990 | Substantially Equivalent |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | Jan 11, 1990 | Substantially Equivalent |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | Nov 23, 1987 | Substantially Equivalent |
| K871182 | FLAME PHOTOMETER STANDARD #60081 120 NA/2K | May 28, 1987 | Substantially Equivalent |
| K871183 | FLAME PHOTOMETER STANDARD #60082 140 NA/5K | May 28, 1987 | Substantially Equivalent |
| K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 | May 28, 1987 | Substantially Equivalent |
| K871185 | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 | May 28, 1987 | Substantially Equivalent |